Health Canada Puts Drug Safety Systems on the Map: The Ball is Now in Industry’s Court
Nov 11, 2016
By Subhan Ahmed
Safety is top of mind for regulatory authorities. As a result, agencies are not only taking a harder line on safety but are also introducing advances, including adopting progressive drug safety systems, to underscore their objective of safeguarding patients and consumers.
In Canada, in 2014 the health ministry was given extensive authority to crack down on drugs that are either dangerous to consumers or where adverse event information is withheld. As a result of the bill passed by the country’s House of Commons, Health Canada has since been allowed to demand warning labels or require a product be removed if it is deemed unsafe. In particular, the bill enables – and the agency now requires – absolute transparency.
Even before the bill was passed, Health Canada had begun taking clear steps to ensure greater transparency and better oversight of data. In April 2013, the agency adopted a comprehensive drug safety database to harmonize and improve the reporting of adverse drug reactions (ADRs) and began receiving adverse reaction reports electronically from marketing authorization holders (MAHs) and clinical trial sponsors. They have implemented an E2B gateway solution from ArisGlobal – database to database transmission – for individual case safety reports (ICSRs). Being compliant with reporting requirements, including E2B compliance, being on time, and ensuring quality data are critical.
Good progress has been made: in 2014, more than 250,000 pre and post market electronic reports were received, compared to the approximate 66,000 domestic reports received in 2013, and today the authority has received more than 1 million ICSRs through the gateway since the start of e-reporting. As of July 2016, more than 90% of all domestic and foreign, pre-market and post-market adverse reaction reports received are now being received electronically. The top 20 MAHs make up 88% of the electronic volume and Health Canada is encourage other companies to go electronic.
What does this mean for industry?
Unfortunately, however, all too many companies are still falling behind with their risk evaluation and mitigation strategies. Of the approximately 200 plus companies registered local with Health Canada, around 50 have begun reporting electronically and another 10 are going through the implementation process. As more companies implement safety databases, the authority is encouraging them to be electronic to ensure reporting compliance as well as timely responses on the confirmations. But with many companies still filing manually, questions are raised about their ability to ensure their processes are in compliance with the agency with regards to safety reporting, which is critical for ensuring the safety of their products.
For industry, there’s an enormous amount riding on staying compliant — both in terms of ensuring the safety of consumers and enabling companies to meet their obligations and get or keep their products on the market.
It’s imperative, therefore, that companies find better ways to manage their safety data reporting, including both clinical trial serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSAR), and spontaneous postmarketing adverse events reporting. It’s about processes, it’s about technology, and it’s about keeping up to date with the authorities.
During this blog series, I’ll explore Health Canada’s specific requirements and how they differ from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) adverse event reporting expectations. I’ll also look at the challenges and potential ramifications of managing safety reporting manually.
Learn more about ARISg and ARISj and why companies and regulatory authorities, including Health Canada, adopt these pharmacovigilance systems for global safety case reporting.